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8.
Do not use the Isiris System during defibrillation as this may result in electrical
shock to the user.
9.
To avoid risk of electric shock, this equipment must only be connected to a
supply mains with protective earth. To disconnect the Isiris System from mains,
remove the mains plug from the wall outlet.
10.
Check that the grasper is not protruding from the endoscope irrigation channel
prior to insertion. The grasper teeth are sharp and can cause damage.
11.
Excessive force should never be used when operating Isiris α, as doing so may
result in mucosal injury.
12.
Always watch the live endoscopic image on the display and adequately
monitor the patient when inserting or withdrawing the scope, and when
operating the grasper, bending section or suctioning. Failure to do so may
result in patient injury.
13.
Electronic equipment may affect the normal function of the Isiris System. If
the Isiris System is used adjacent to or stacked with other equipment, observe
and verify normal operation of the Isiris System prior to using it. The Isiris
System may cause interference or disrupt equipment operations nearby. It
may be necessary to adapt procedures for mitigation, such as reorientation or
relocation of the equipment.
14.
Do not activate the grasper when the distal end is inside the urethra as this may
result in serious injury to the patient.
15.
Do not enter any part of the Isiris α into the ureter as this may result in injury to
the patient.
16.
The Isiris α is not designed for introduction of endoscopic instruments. Do not
try to introduce any device or contrast agent through the irrigation connector,
as this may damage the graspers functionality.
17.
The maximum allowed irrigation pressure limit is 200 cmH₂O or 0,2bar.
Exceeding this limit may result in serious injury to the patient.
18.
The distal end of the endoscope may get warm due to heat from the light
source. Avoid long periods of contact between the tip of the device and the
mucosal membrane as long, sustained contact with the mucosal membrane
may cause mucosal injury.
19.
During removal of the double loop stent, it is the user's responsibility to
evaluate the pull strength and adapt the removal force and speed. Never exceed
the usual pulling force as it may damage the patient's urinary tract.
20.
Always perform a visual check according to the instructions in section 4 before
placing the Isiris α in a waste container to ensure that no parts are left inside
the patient.
21.
Isiris α is considered infected after use and must be disposed of in accordance
with local guidelines for collection of infected medical devices with electronic
components.
22.
Disconnect Isiris Monitor from any mains power supply, remove any accessories
and make sure Isiris Monitor is completely turned off before cleaning and
disinfection. The equipment is disconnected from mains by removing the mains
plug from the wall outlet
CAUTION
1.
Do not use sharp instruments to open the pouch or cardboard box as this could
damage the sterile barrier and compromise the scope. Use standard medical
practice for handling sterile equipment.
2.
Make sure to have a suitable backup system readily available in case a
malfunction should occur.
3.
Keep the Isiris α handle dry during preparation and use, as liquid can cause a
short circuit and affect the displayed image.
4.
The Isiris System consists of the parts described in section 2. Failure to comply
with this may reduce safety and efficiency.
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02/06/2022 17:47
02/06/2022 17:47
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